ObesityOBIMPACOVNCT04910607
Social and Psychological Impacts of SARS-Cov-2 Pandemic Period in the Obese Population.
An observational study of Obesity and Covid19, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
The population suffering from obesity is particularly at risk during this pandemic period. The Nouvelle Aquitaine region is not spared, since according to the regional epidemiological report of 7 May 2020, carried out by Santé Publique France, 39.2% of cases admitted to the intensive care unit in Nouvelle Aquitaine… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Questionnaire and Interview
- How many people
- 279 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Jan 2022to 28 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The obese population is the target population of the study.
Who may be able to join
- Patients 18 years of age.
- Be registered in an active file of the 3 partner CSOs.
Who cannot join
- Patients under 18 years of age.
- Patients under protective measures or deprived of liberty:
- pregnant or breastfeeding woman,
- under guardianship,
- under guardianship,
- safeguard of justice,
- incarcerated.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Limoges
Limoges, 87042
Hôpital Haut-Lévêque
Pessac, 33604
CHU de Poitiers
Poitiers, 86000
About this study
The population suffering from obesity is particularly at risk during this pandemic period. The Nouvelle Aquitaine region is not spared, since according to the regional epidemiological report of 7 May 2020, carried out by Santé Publique France, 39.2% of cases admitted to the intensive care unit in Nouvelle Aquitaine and presenting risk factors are overweight or obese.
Other risk factors, such as social-environmental factors, must be taken into consideration. Socio-demographic surveys in this area highlight the socio-economic and territorial inequalities that interfere with obesity issues. Similarly, the issues of stigmatisation and isolation seem to be at the heart of the question of how to deal with these people.
Read the detailed description
This is a prospective multicentre study. Participating patients will be recruited from the Specialised Obesity Centres (CHU and SSR, as well as patient associations) to fill in a questionnaire and take part in an interview (a varied panel representative of the target population in terms of place of residence, socio-professional category, sex and age).
The medical and paramedical staff involved in the partner CSOs and the patients' resources (identified by the patients' associations) will also be asked to participate in a semi-directive interview.
- Being tested
- Questionnaire, Interview
- Keywords
- Obesity, COVID19, semi-directive interview
- Medical subject headings
- Obesity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire with 4 axes:
sociological, reflexive medical, prospective medical, transversal
InterviewOther
Interview concerning health pathways, experience of confinement, consequences of confinement on health, representations of obesity.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Participating patients will be recruited from the Specialised Obesity Centres =CSO (CHU and Follow-up and rehabilitation care (SSR), as well as patient associations) to fill in a questionnaire and take part in an interview (varied panel representative of the target population in terms of place of residence, socio-professional category, sex and age). Receives: Other: Questionnaire; Other: Interview | |
| Professional | Medical and paramedical staff involved in the partner CSOs will also be asked to participate in a semi-structured interview. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysed social and psychological impacts of containment
Thanks to sociology questionnaire based on the experience and paths of individuals (not a score).
The treatments carried out will be limited to cross sorting and flat sorting, factorial analyzes and -previously- the chi-square analysis.
Measured: 9 months after inclusion day
Consequences of social distancing during the containment
Thanks to sociology questionnaire based on the experience and paths of individuals(not a score).
The treatments carried out will be limited to cross sorting and flat sorting, factorial analyzes and -previously- the chi-square analysis.
Measured: 9 months after inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start21 Jan 2022
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Région Nouvelle Aquitaine
- Responsible party
- Sponsor
- Investigators
- Arnaud ALESSANDRIN, Dr, Study chair, Universite de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910607
- Sponsor's protocol ID
- CHUBX 2020/38
- Acronym
- OBIMPACOV
- Status last verified
- Dec 2023
- First submitted
- 16 Apr 2021
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Psychological Impacts of SARS-Cov-2 Pandemic Period in the Obese Population.
- ClinicalTrials.gov ID
- NCT04910607
- Acronym / sponsor ID
- OBIMPACOV / CHUBX 2020/38
- Keywords
- Obesity, COVID19, semi-directive interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Région Nouvelle Aquitaine
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The population suffering from obesity is particularly at risk during this pandemic period. The Nouvelle Aquitaine region is not spared, since according to the regional epidemiological report of 7 May 2020, carried out by Santé Publique France, 39.2% of cases admitted to the intensive care unit in Nouvelle Aquitaine and presenting risk factors are overweight or obese.
Other risk factors, such as social-environmental factors, must be taken into consideration. Socio-demographic surveys in this area highlight the socio-economic and territorial inequalities that interfere with obesity issues. Similarly, the issues of stigmatisation and isolation seem to be at the heart of the question of how to deal with these people.
Detailed description
This is a prospective multicentre study. Participating patients will be recruited from the Specialised Obesity Centres (CHU and SSR, as well as patient associations) to fill in a questionnaire and take part in an interview (a varied panel representative of the target population in terms of place of residence, socio-professional category, sex and age).
The medical and paramedical staff involved in the partner CSOs and the patients' resources (identified by the patients' associations) will also be asked to participate in a semi-directive interview.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Questionnaire, Other: InterviewParticipating patients will be recruited from the Specialised Obesity Centres =CSO (CHU and Follow-up and rehabilitation care (SSR), as well as patient associations) to fill in a questionnaire and take part in an interview (varied panel representative of the target population in terms of place of residence, socio-professional category, sex and age). |
| Professional | – | Other: InterviewMedical and paramedical staff involved in the partner CSOs will also be asked to participate in a semi-structured interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The obese population is the target population of the study.
Key inclusion criteria (2 listed)
- Patients 18 years of age.
- Be registered in an active file of the 3 partner CSOs.
Key exclusion criteria (7 listed)
- Patients under 18 years of age.
- Patients under protective measures or deprived of liberty:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire with 4 axes: sociological, reflexive medical, prospective medical, transversal | Other | Patient |
| InterviewInterview concerning health pathways, experience of confinement, consequences of confinement on health, representations of obesity. | Other | Patient, Professional |
Primary outcome
Analysed social and psychological impacts of containment
Time frame: 9 months after inclusion day
Thanks to sociology questionnaire based on the experience and paths of individuals (not a score). The treatments carried out will be limited to cross sorting and flat sorting, factorial analyzes and -previously- the chi-square analysis.
Consequences of social distancing during the containment
Time frame: 9 months after inclusion day
Thanks to sociology questionnaire based on the experience and paths of individuals(not a score). The treatments carried out will be limited to cross sorting and flat sorting, factorial analyzes and -previously- the chi-square analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud ALESSANDRIN, Dr study chair
Universite de Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Covid19, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysed social and psychological impacts of containment (time frame: 9 months after inclusion day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.